Numerous medical procedures involve percutaneous insertions into a blood vessel, such as for example the femoral artery. Among the more common procedures are diagnostic and therapeutic intervention, such as for example balloon angioplasty and stent placement, brain artery catheterization, cardiac catheterization, intra-aortic balloon pumping (IABP) and percutaneous transluminal coronary angioplasty (PTCA). Each of these procedures typically begins with the placement of an angiographic needle through the skin and tissue of the patient's leg at a pulse point of the femoral artery immediately below the inguinal or groin crease. The needle is introduced until the tip of the needle has entered the femoral artery. A guidewire is then inserted through the needle and up through the femoral and iliac arteries until the guidewire reaches the desired location. The needle may then be removed, leaving the guidewire in place to serve as a guide for the insertion of an introducer sheath assembly.
It takes a considerable amount of skill to be able to locate a femoral artery or other targeted blood vessel, stabilize it, and then insert the needle so as to minimize pain to the patient. If the needle is not perfectly pointed towards the blood vessel, the blood vessel will often move laterally, or “roll,” away from the needle as soon as the initial pressure is applied to the blood vessel. When the blood vessel rolls away from the needle or the needle misses the blood vessel, it is necessary to repeat the procedure causing discomfort and anxiety for the patient. Rolling is a particularly common problem because the blood vessel is embedded in soft tissue and has more mobility.
Traditionally, caregivers attempt to localize the path of the blood vessel with their fingers. This procedure however is fraught with the danger of the caregiver puncturing one of his or her fingers with the needle and being subjected to the risks of acquiring blood borne diseases such as hepatitis B and HIV infections and bacterial infections at the puncture site.
Various devices have been devised for vascular stabilization or positioning, such devices tend to be rather elaborate, requiring in many instances a positive mounting to the arm or the like. Known devices also tend to have limited utility insofar as being capable of accommodating, with a single instrument, the many variations that exist among different patients as well as the particular arteries and veins that are positioned, stabilized and retained during puncture.
One group of such devices at least partially blocks the flow of blood through the targeted blood vessel while stabilizing the vessel. Examples of such devices are described in U.S. Pat. No. 1,561,116 (Silliman), U.S. Pat. No. 3,324,854 (Weese), and U.S. Pat. No. 4,586,924 (Lanning). These devices generally include a surface portion that compresses the skin so that blood flow is restricted in the vessel. When force is applied to the portion against the skin, the vessel tends to bulge from the excess blood obstructed by the device. In particular, U.S. Pat. No. 1,561,116 (Silliman) describes a vein stabilizer that includes a handle and a substantially flat blade portion having a notch. The flat blade portion is adapted to be pressed over a distended vein to close one end of the vein so that the vein projects through the notch.
U.S. Pat. No. 2,103,174 (Posada) describes a device that restricts blood flow in a blood vessel with a strap and retains the blood vessel with a vein retaining plate. The strap serves as a tourniquet functioning to turn off or restrict the blood flow from the upper arm to the forearm. The vein retaining plate is made of spring metal material. The vein retaining plate is a substantially rectangular configuration and is dished or bowed so that the outer marginal edges of a pair or legs or arms lie in a plane above the plane of the inner marginal edges of said legs. The vein retaining plate also includes a convex strip that functions as a spring so that in the operation of the device, the width of the opening that extends between the inner edges of the arms or legs may be readily diminished by merely pressing the fingers on the sides of the arms or legs.
Another group of devices may allow blood to flow through the targeted blood vessel while it is stabilized, but do not allow for rotational positioning against the patient during stabilization to expose the targeted blood vessel. These types of devices are described in U.S. Pat. No. 4,332,248 (DeVitis), U.S. Pat. No. 5,254,095 (Harvey), and U.S. Pat. No. 5,415,647 (Pisarik). In particular, U.S. Pat. No. 5,254,095 (Harvey) describes a stabilizer for blood vessels that includes a pair of diverging panels integrally joined at a bight portion which in turn defines a hinge between the panels. The panels have outer edges with extending legs for engagement with and manipulation of the skin for the positioning and stabilizing of veins.
Still another group of devices do not stabilize a targeted blood vessel. Rather, these devices guide a needle into a blood vessel at a particular angle. U.S. Pat. No. 5,292,325 (Gurmarnik) describes a device and a method for facilitating subcutaneous introduction of a plastic carrier that includes an element having a supporting portion arranged to be supported on the skin of a patient, and a guiding portion extending substantially transversely to the supporting portion and having at least one slot formed so that when the supporting portion is placed on the skin of a patient and oriented on a surface projection line of an artery and a catheter is introduced through the slot of the guiding portion, the catheter is guided on an edge formed in the guiding portion by the slot so that a tip of the catheter is introduced exactly into the artery.
U.S. Pat. No. 5,911,707 (Wolvek, et al.) describes a needle guide that ensures that an angiographic needle is inserted into a patient's femoral artery at a prescribed location, angle and direction. The needle guide includes an elongated base having a recess on one end defined by a pair of projecting fingers, and a support member on the upper surface of the base adjacent to the recess. The support member has a support surface which is inclined at a prescribed angle with respect to a locating plane defined by the base. A channel in the support surface cradles and guides the angiographic needle at the prescribed angle as it is inserted into the femoral artery.
U.S. Pat. No. 4,572,182 (Royse) describes a pressure pad for use on an artery clamp of the type used to apply pressure following catheterization of a major artery. The pad includes a notched portion to facilitate placement of the pad over a catheter prior to removal of a catheter from a patient's artery. The pad is removably attached to an artery clamp.